Sunday, January 29, 2012

. . . The potential benefits of the research do not justify the potential dangers, so the research should be discontinued. While in almost all circumstances basic research should be fully disseminated in the science community, in this case the results should not be published in a way that allows them to be replicated by others. If allowed to continue, the research should be performed only in pursuit of concrete, urgent goals under international approval and the greatest possible safety conditions.

TOM INGLESBYBaltimore, Jan. 24, 2012

The writer, an infectious-disease doctor, is director of the Center for Biosecurity, University of Pittsburgh Medical Center.

Thursday, January 26, 2012

... I feel pretty confident a primary factor behind the incident and the university's response to it is clear enough: hubris.

UW football is a powerful, beloved institution, and this wouldn't be the first time men of powerful, beloved institutions thought the usual rules didn't apply to them. ....

Chris Rickert is a columnist for the Wisconsin State Journal. The incident he's writing about is the embarrassing revelation that senior UW-Madison football staff have for years been providing liquor to under-aged students and apparently in some cases have been using their authority to force the students into having sex with them; and as far as the drunken parties alone are concerned, the head coach and the sports director have known about it for years.

The crazy thing is that Rickert says that the athletic senior staff think the usual rules didn't apply to them. Hello?

The university administration and much of the senior staff doen't think the usual rules apply to them, and they are right. It's not an opinion limited to the football staff.

When it was discovered that university vivisectors were matter-of-factly breaking state law by killing sheep with atmospheric decompression, the university went to the Legislature, snapped their fingers, and just like that, pop, without any opportunity for public discussion, the state's anti-cruelty laws no longer applied to them.

They simply don't believe the usual rules apply to them. And they are right. We live in a tiered society where rules and laws that govern people like me and Rickert are unimportant to the likes of institutions like UW-Madison.

The rather sad thing is that Rickert has not noticed this until now and probably will always imagine it's something unique to the athletic department.

Wednesday, January 25, 2012

.... More than a dozen flu experts contacted by Nature say they believe that the work opens up important vistas in basic research, and that it sends a valuable warning about the potential for the virus to spark a human pandemic. But they caution that virus surveillance systems are ill-equipped to detect such mutations arising in flu viruses. As such, work on the viruses is unlikely to offer significant, immediate public-health benefits, they say.

That tips the balance of risk–benefit assessment in favour of a cautious approach, says Michael Osterholm, who heads the University of Minnesota’s Center for Infectious Disease Research and Policy in Minneapolis, and who is a member of the US National Science Advisory Board for Biosecurity (NSABB).

...

Again... where was the initial thoughtful, insightful oversight that is claimed to guide and regulate taxpayer-funded research?

I repeat: We ought to destroy all the petri dishes, all the records, everything we have that might allow us to move forward with this line of research. The researchers themselves ought to be forced into retirement and banned for life from having any contact with any germ lab. Oversight committees that approved the research ought to be disbanded and new more rational people selected to serve on them. Agencies that approved and funded the research ought to be purged of anyone who voted for or signed off on the approval of funding this absolute insanity.

Interesting related bit:Virus in one controversial H5N1 study wasn't lethalJan 25, 2012 (CIDRAP News) – Breaking a prolonged silence, the author of one of two controversial studies dealing with mutant H5N1 viruses said today that the virus his team created went airborne to spread among ferrets, but it didn't kill them.

When I was injected in the back of the neck I was being held in isolation, so I was unable to discuss what had happened with other detainees. A year passed before I was eventually able to see and communicate with fellow detainees, and I am unable to remember today if I discussed that particular personal experience with them. We did discuss medical experimentation in general however. A detainee with UK citizenship described being injected daily, resulting in one of his testicles becoming swollen and racked with pain. Along with these daily injections he was subjected to mind games by interrogators, medical personnel, and guards whom worked as a team. Under these conditions they were able to extract written false confessions from him. How I experienced the injection at the base of my neck is described in detail in my book. In a nutshell, I felt my soul had been violated. That is just one experience I had with medication. There were many pills and injections, plus constant blood tests over the years. Everybody regardless of their citizenship should acknowledge that medical experimentation, whether on human beings or animals, is unacceptable. As with animals, we were held as prisoners when these procedures were forced upon us against our will. And as with animals, we were voiceless.

I've mentioned many times how cruel, dull, insensitive, distrustful, and contriving I find members of the vivisection industry to be. I've mentioned UW-Madison's Harlow Lab director Chris Coe by name a couple times. See for instance The Biology of Iron and Christopher Coe on Res 35. Or, just stick "Coe" into the little search window at the top of the page in the upper left. But I'm going to have to add gullible to my list of descriptive adjectives.

Regular readers may recall that UW-Madison successfully derailed an effort to encourage public involvement in a consideration of the ethics of using monkeys in its research programs. A key component of this deflection of public scrutiny was the promise they made to the Dane County Board of Supervisors to hold a series of public forums that would adequately answer any questions that the public might have about the university's use of animals. (I summarize and paraphrase here; for more, read: "Forum" Keeps Details Hidden.)

The forums have been a sham but they have nevertheless fooled even those they are meant to shield. The most recent forum featured a presentation by Andrew Rowan of the Humane Society of the United States. He gave an interesting talk, but had no specific knowledge about anything having to do with the university's use of animals.

Here's the silly connection with Coe: When he heard that Rowan was coming he sent the members of the forum committee information that he claimed exposed HSUS for what it really is. His information about HSUS was Rick Berman's industry-funded HumaneWatch.org. Really? So much for critical thinking.

Tuesday, January 24, 2012

You may or may not have noticed dramatic headlines over the last few weeks regarding research on the deadly avian flu virus. A variety of news sources have led with titles noting a "mutant killer virus" and "science gone wrong."

It can be really hard to distinguish the truth from the drama, especially when a controversy places your university under the media microscope.

I'm not sure what to make of this article. It appears to be simple PR spin rather than actual reporting. But the author is a new grad student who is listed as a research assistant trainee at the INSTITUTE FOR MOLECULAR VIROLOGY which leads me to think that she might actually believe what she wrote. If she were in one of the journalism programs, I'd think she was just completing an assignment on fooling the public.

What makes this article sort of interesting is that she is probably just voicing the chatter she's hears where she works. Lab personnel are particularly susceptible to the negative effects of conforming to group norms, obedience to authority, and the other well researched and documented risks of group identification, particularly when there is a perceived in-group and out-group. This phenomena is on full display whenever one takes the time to observe the group behavior of the university's vivisectors and the administrators, staff and faculty associated with their work. (My favorite work on this dark and interesting part of human behavior is Phillip Zimbardo's The Lucifer Effect: Understanding How Good People Turn Evil. 2007. The second half of the book amounts to a survey of many studies and situations that demonstrate the risks of "situational influences.")

As a result of being a part of a group that probably feels somewhat under attack at the moment, and listening to the likely uncritical self-supporting and self-justifying conversations, its little wonder that she is so confused and feels a need to tell her fellow students the "truth." No matter how limited the local news coverage has been, it is a near certainty that the staff and students associated with the virology labs at UW-Madison are keenly aware of what's being reported elsewhere. The author understandably has projected her personal interest onto the rest of the student body. (I doubt that more than a handful of non-biology students even know that there is a storm raging over the work at their university.)

Anyway, I thought I'd take a moment here to look at her statements because they very likely reflect the opinions of those in the labs she believes to be the "true" authorities on the questions surrounding the invention of what may be, so far as humans and perhaps some other mammals and some birds are concerned, the most dangerous virus on the planet.

She says that the world-wide concern is media-induced. She calls it "media-induced fear." But the risk isn't a media contrivance. I would say that the fear is scientist-informed. The earliest alarms seem to have been raised by people like Ian Ramshaw of Canberra's National Centre for Biosecurity (NCB) and Richard Ebright, a molecular biologist at Rutgers University and the Howard Hughes Medical Institute. Ebright apparently said early on that the research should never have been conducted in the first place because of the grave public health risks.

The outspoken concern by authoritative scientists -- urging the censoring of the details of this work -- is very unusual. Very unusual too, maybe even unique, is the request from the National Institutes of Health (under the direction of the National Science Advisory Board for Biosecurity) to the world's two premier science journals, Science and Nature, not publish papers detailing how this new version of the bird flu was created. (See Fears grow over lab-bred flu: Scientists call for stricter biosafety measures for dangerous avian-influenza variants. Declan Butler. Nature. 20 December 2011.)

Unlike most local Madison news outlets, reporters in other markets, particularly science reporters, took notice and explained to the public why there is such largely unprecedented concern among scientists about this research.

The author then mentions the potential risks, but dismisses them with a claim about the potential benefits of the research.

Throw in the fact that the H5N1 flu has killed nearly 60% of humans who have contracted it (though only 570 people have been infected worldwide) and you can understand the current media-induced fears-that scientists are providing bioterrorists with instructions to create a virus that would kill more than half of the human population.

Again, that's pretty dramatic. Not only does such a statement ignore the practical limitations of flu infection and laboratory science, but also the more important reasons for performing such research and the role of regulatory measures in preventing such a situation.

But her justification is the mantra of all basic biomedical research -- speculative benefits that rarely come to pass. In this case, it's like saying we ought to invent a doomsday time-bomb so that we can learn how to defuse it. That's nuts, but nutty beliefs are one of the common results of the sort of situational influences examined by Zimbardo.

The author seems unable to see what is in front of her, even when she writes it down. She says: "In an introductory article from Science Insider (of the journal Science), Fouchier is quoted saying that his lab created what is 'probably one of the most dangerous viruses you can make.'" That seems like a pretty clear statement about the danger given the sometimes high mortality associated with other viruses that are here naturally.

The author has apparently no knowledge of the history of the biosecurity failures in the U.S., abroad, or at her own institution. She says:

Regarding any fears that harmful viral agents could escape from such laboratory spaces, the measures taken by the IIVR represent "the most stringent set of federal guidelines I've ever seen," according to James Tracy, former associate dean of the School of Veterinary Medicine, in the On Wisconsin article. Previously, federal research funding agencies, like the National Institutes of Health, would have had to approve Kawaoka's research.

This is an odd statement. A very odd statement. Surely she knows that Kawaoka's lab's most secure space is classified as Bio-Safety Level-3-Agriculture, or just BSL-3-Ag.

A BSL-3-Ag lab is a safer place to handle dangerous pathogens than a a BSL-1 or BSL-2 certified lab. A BSL-3-Ag lb has special requirements because large "loosely" housed animals are used. You can read some of the technical details here.

But as safe and secure as the Kawaoka BSL-3-Ag area is, it's no BSL-4 lab. These two photos from the CDC give some sense of the difference:Notice that the fellow on the left has the back of his head exposed and is wearing a lab coat over his clothes. The people on the right are more or less in space suits.

James Tracy's comment about a lab at the UW-Madison having "the most stringent set of federal guidelines" that he'd ever seen is silly and either intentionally misleading or based on an absence of knowledge. (Frankly though, I don't think Tracy's comments should be given much weight, regardless of what he says. In my opinion he intentionally mislead the public about what has taken place at the university. Thankfully he's no longer at the university. See my response to a letter to the editor from him here: Millions dead within weeks.

The author provides her readers with a reassuring balm: "With respect to the publication of results, the National Science Advisory Board for Biosecurity (NSABB) has been called in, as it has been for similar situations in the past."

Unfortunately, there has only been one other case that could in any way been seen as somewhat similar, and that was the crazy resurrection of the previously extinct 1918 Spanish flu. Read my essay linked to above for more on Kawaoka's involvement in that affair.

But even that insanity is dwarfed by the craziness of creating even deadlier diseases.

If in fact, the author's opinions reflect those of her superiors and virus lab co-workers, then we ought to be concerned about their faith in the system and their failure to take note of the many problems on their own campus regarding biosafety. I suspect, as I said at the start, that her opinions on this matter give us a very good indication of what's being said in the virus labs on campus. That's not cause for comfort.

I'll give Ms. Michael the last word here. She sums up with her expression of faith and pride. She is one of the insiders, proud to be part of the elite club that sees all the current controversy as just so much media-induced nonsense. You can't argue with faith:

While the NSABB has yet to make a decision, there are many factors for audiences to consider in judging for themselves. Either way, UW-Madison's place in such a debate is an example of its prominence in such worldwide research efforts.

Monday, January 23, 2012

A Call to Stop H5N1 ResearchSabrina Richards. The Scientist. January 23, 2012....Among the changes needed, “we should have in place a system of prior review,” Ebright said, such as a group of disinterested parties tasked with weighing the risk of such studies.

There's an idea! And it puts the lie to the tired claim made by every U.S. vivisector, university, and the other institutions involved in similar work, that there is already extensive prior review.

This is comforting:

Steinbruner argues for keeping “professional regulators” out of the picture for now in order to come to a conclusion more quickly. “Scientists must take the initiative to find an arrangement [of regulations] they can live with” before disaster strikes, he said. Though the name may not inspire the same nightmares as Ebola or anthrax, influenza may be the perfect agent for a pandemic, with H5N1 showing greater than 50 percent mortality in the five hundred people who have contracted the virus directly from infected poultry—well above the 2.5 percent mortality rate of the 1918 flu, which killed over 50 million people. “There’s nothing else in its league,” Steinbruner said.

Wouldn't you think that brewing up something this dangerous ought to be a topic of serious discussion in Madison, home of one of the two labs in the world with this bomb on the shelf? The fact that it hasn't been has a lot to say about how well local media are keeping the public apprised. It says something about local media's reluctance to say anything that could lead to negative opinions about the university. The risk to the public, coupled with the past problems in Yoshihiro Kawaoka's lab with Ebola, would seem a reasonable and important topic for public discussion.

Wouldn't you think that the state's university where this research is occurring ought to be holding public forums about it? Maybe public education isn't a high priority for them.

Maybe they don't care what the public knows or thinks.... that's how it looks to me.

Sunday, January 22, 2012

Researchers studying a potentially more lethal, airborne version of the bird flu virus have suspended their studies because of concerns the mutant virus they have created could be used as a devastating form of bioterrorism or accidentally escape the lab.

Monday, January 16, 2012

When flu scientist Ron Fouchier, of Erasmus University in Rotterdam, announced in September that he had made a highly contagious, supervirulent form of the bird-flu virus, a long chain of political events unfolded, mostly out of the public eye. Fouchier told European virologists at a meeting in Malta that he had created a form of the H5N1 avian flu — which is extremely dangerous to both birds and mammals, but only contagious via birds — that was both 60 percent fatal to infected animals and readily transmitted through the air between ferrets, which are used as experimental stand-ins for human beings. The University of Wisconsin’s Yoshihiro Kawaoka, one of the world’s top influenza experts, then announced hours later that his lab had achieved a similar feat. Given that in some settings H5N1 has killed more than 80 percent of the people that it has infected, presumably as a result of their contact with an ailing bird, Fouchier’s announcement set the scientific community and governments worldwide into conniption fits, with visions of pandemics dancing in their heads. Read more....

This is an interesting and informative piece; it's good that the Cap Times published it.

As interesting and apparently well-researched as this article is, it fails to call attention to the history of accidents associated with research involving dangerous infectious diseases. The level of risk from terrorists using germ warfare seems low when considered against the history of problems that have resulted from things like poor maintenance of rubber seals and ventilation systems in supposedly secure laboratories, workers becoming blasé about biosafety, and plain old mistakes and accidents.

Plum Island

Lyme disease takes its name from Lyme, Connecticut. (I marked Lyme and Plum Island on the map above.) Some people consider it more than coincidental that tick-borne diseases were being studied at USDA's Animal Disease Center on Plum Island, when the disease emerged in the US population. Plum Island, "The Safest Lab in the World" has also been suggested as the US doorway of West Nile virus, and duck enteritis. For much more on this see Lab 257: The Disturbing Story of the Government's Secret Plum Island Laboratory.

Pirbright

The likely cause of the 2007 outbreak of foot-and-mouth disease in the United Kingdom, which resulted in thousands of animals being destroyed and costing billions of pounds, apparently was traced to leaky sewage pipes damaged by tree roots. The laboratory itself maintained good biosafety standards apparently, and still, a breach occurred. (See too 'Safety incidents' at animal lab. May 2011. BBC.) Even after the 2007 disaster, accidents continue. Accidents are just a part of life; they happen, accidentally. There are no absolutely fail-safe systems.

NIAID Encourages Use of Leaky Device in BiodefenseChambers are Located in Nine US States, India, New Zealand, and Northern Ireland

(Austin, 18 April 2005) - A leaky aerosol chamber manufactured by the University of Wisconsin at Madison was responsible for three laboratoryhttp://www.blogger.com/img/blank.gif-acquired tuberculosis infections in a Seattle BSL-3 lab last year. The infections have not been made public until now. Nearly twenty Madison chambers exist across the US and in India, New Zealand, and Northern Ireland. While tuberculosis is not a biological weapons agent, the accident underscores the inherent dangers when working with dangerous disease agents, and the grave safety risks of the US biodefense program, which is encouraging more scientists to deliberately aerosolize bioweapons agents in Madison chambers and similar equipment.

The Madison aerosol exposure chamber was developed by the University of Wisconsin in 1970 as a stand-alone system designed for total body exposure of animals as small as mice or as large as rabbits. The chamber, which can hold up to 90 mice, allows researchers to simultaneously infect large numbers of animals. It is essentially a pressure vessel that contains a nebulizer, which is filled with a particular agent that is drawn through the chamber to completely expose the animals. During exposure, the aerosol is contained within the system and a purge cycle following aerosolization reduces lingering agents. The chamber, designed for specialized BSL-3 and BSL-4 labs, is being used today to study tuberculosis, bioterrorism agents, anthrax, and any research that requires the infection of a large number of animals.

In recent media coverage of this new-to-the-world most-deadly-flu-ever, UW-Madison's William Mellon, who oversees the university's program for pathogens and toxins, has been saying that biosafety and security at UW-Madison "are among the most rigorous in the world."

I don't know whether Mellon is intentionally lying, but he isn't being entirely forthcoming. And while, if given the chance, the UW-Madison biosafety oversight system might function as well as similar systems elsewhere ("most rigorous in the world" is clearly hyperbole) accidents and mistakes still occur.

Today, biologists can insert genes directly into germs' genetic codes and give them characteristics that do not occur in nature. One of the characteristics that can sometimes be inserted is a resistance to the antibiotics used to control the germ. Research involving the artificial of creation of antibiotic resistant germs is termed a "Major Action" under the NIH Guidelines, and requires specific permission to do so from them.

The claimed benefits from inventing new-to-the-world diseases may or may not be accurate, but the risks are real. The scientist at UW-Madison involved in the invention of the new deadlier-than-ever bird flu is Yoshihiro Kawaoka. Kawaoka knows a lot about viruses, but he has a history of being a little too unconcerned about the risk to his neighbors.

He was working with Ebola in his UW-Madiswon lab, and asked the NIH for permission to reduce the level of biosafety measures he was using.

In 2005 and into the summer of 2006, researchers at the University of Wisconsin at Madison (UW) made and manipulated copies of the entire Ebola virus genome without proper safety precautions. Although federal safety rules required a maximum protection Biosafety Level Four (BSL-4) lab for the research, UW allowed it to proceed at the much less safe and secure BSL-3 level. The rules that UW broke are intended to ensure that agents that are easily transmissible and usually incurable don't escape maximum containment. They prohibit working at BSL-3 with Ebola (and similarly dangerous) virus material that has not been rendered irreversibly incapable of reproducing. UW does not have a BSL-4 lab suitable for handling Ebola virus, which is one of the most dangerous pathogens in the world.

Despite the contrary provisions of the NIH Guidelines for Research Involving Recombinant DNA Molecules, permission for UW scientist Yoshihiro Kawaoka to perform the Ebola genome work at BSL-3 was granted by the University of Wisconsin Institutional Biosafety Committee (IBC). This significant violation of NIH Guidelines was not detected in a timely manner by the National Institutes of Health (NIH) or, apparently, by the CDC Select Agent Program staff that inspect the Kawaoka lab....

The country was gearing up to go to war. The lesson had been learned. The main killer in war, at the time, wasn't the enemy, it was disease:

Twice as many men died of disease than of gunshot wounds in the Civil War. Dysentery, measles, small pox, pneumonia, and malaria were the soldier's greatest enemy. The overall poor hygiene in camp, the lack of adequate sanitation facilities, the cold and lack of shelter and suitable clothing, the poor quality of food and water, and the crowded condition of the camps made the typical camp a literal breeding ground for disease. Conditions, and resulting disease, were even worse for Civil War prisoners, who were held in the most miserable of conditions. (From Civil War Medicine.)

Hospital beds were ready; isolation wards at hand. This time, the country would take care of its soldiers and get them back in action as fast as possible. We had learned the lesson: hygiene and quarantine were key.

But then came the 1918 Spanish flu. Before men were sick enough to be diagnosed and isolated, they had already infected others:

The lowest estimate of the pandemic's worldwide death toll is twenty-one million, in a world with a population less than one-third today's. That estimate comes from from a contemporary study of the disease and newspapers have often cited it since, but it is almost certainly wrong. Epidemiologists today estimate that influenza likely caused at least fifty million deaths worldwide, and possibly as many as one hundred million.

...Although the influenza pandemic stretched over two-years, perhaps two-thirds of the deaths occurred in a period of twenty-four weeks, and more than half of those deaths occurred in even less time, from mid-September to early December 1918. Influenza killed more people in a year than the Black Death of the middle ages killed in a century; it killed more people in twenty-four weeks than AIDS has killed in twenty-four years. John M. Barry. The Great Influenza. (2004) pp 4-5 passim

The 1918 Spanish flu is the most deadly disease yet encountered during historical times. The new-to-the-world super-flu invented by Kawaoka and Ron Fouchier is thought by some to be just as deadly, and perhaps even worse. The institutions, labs, and the researchers that already have and those that might might gain access to the recipe for making this potentially species-eliminating new plague are mere humans, possessing all the weaknesses of distraction, hubris, and greed that affect everyone else. No knowledge is so valuable, so important, that its possession trumps such grave risk. The history of biosafety failures -- many more than are mentioned here -- ought to give us pause.

We ought to destroy all the petri dishes, all the records, everything we have that might allow us to move forward with this line of research. The researchers themselves ought to be forced into retirement and banned for life from having any contact with any germ lab. Oversight committees that approved the research ought to be disbanded and new more rational people selected to serve on them. Agencies that approved and funded the research ought to be purged of anyone who voted for or signed off on the approval of funding this absolute insanity.

Friday, January 13, 2012

We need to fix the holey biosafety net. NewScientist13 January 2012 Research into lethal flu should not have got so far without scrutiny

PHYSICS lost its innocence on 16 July 1945, when researchers involved in the Manhattan Project witnessed the first detonation of an atomic bomb. Years later, Robert Oppenheimer recalled that he was haunted by a verse from the Hindu scripture, the Bhagavad Gita: "I am become death, the destroyer of worlds."

Ron Fouchier and Yoshihiro Kawaoka haven't yet revealed their thoughts on learning that they had created flu viruses that could potentially kill tens of millions of people (see "One mistake away from a worldwide flu pandemic"). But with opinion divided on the wisdom of running the experiments, biology may have crossed a similar line.

The circumstances are very different, of course. Oppenheimer and his colleagues were trying to defeat tyranny. Fouchier and Kawaoka were motivated by a desire for knowledge that they argue will make the world safer.

The trouble is that in the wrong hands, or if handled carelessly, these viruses may be just as dangerous as a nuclear bomb. More....

The unspoken, unasked, perhaps unnoticed question with the gravest implication, is why didn't local "experts" see the clear risk -- the lunacy -- in the scientists' plans and stop them?

As if you can't can't guess why..... Such craziness won't stop as long as greedy madmen are at the helm.

Monday, January 9, 2012

After reading my repeated postings about the local newspapers' silence about the now world-wide concerns about the invention of the new deadlier-than-ever flu virus invented at the University of Wisconsin, Madison and in Holland, a friend of mine sent an email to a reporter at the Cap Times, Todd Finkelmeyer, and to an editor at the Wisconsin State Journal, Scott Milfred, asking them why they weren’t covering this story.

Finkelmeyer wrote back pointing to his work on this (which I had completely missed), and to my chagrin, Finklemeyer has done a good job:

Saturday, January 7, 2012

Editorial

An Engineered Doomsday

Published: January 7, 2012

Scientists have long worried that an influenza virus that has ravaged poultry and wild birds in Asia might evolve to pose a threat to humans. Now scientists financed by the National Institutes of Health have shown in a laboratory how that could happen. In the process they created a virus that could kill tens or hundreds of millions of people if it escaped confinement or was stolen by terrorists.

We nearly always champion unfettered scientific research and open publication of the results. In this case it looks like the research should never have been undertaken because the potential harm is so catastrophic and the potential benefits from studying the virus so speculative. [My emphasis.]

Wednesday, January 4, 2012

Vivisectors uniformly argue that medical progress is dependent on their continued access to animals. Their lobbying organizations work diligently toward more or less unfettered freedom for vivisectors to treat animals as they wish. They never make the claim so baldly, but their actions -- like the University of Wisconsin successfully lobbying state lawmakers in 2011 to exempt them from the state's anti-animal cruelty laws -- speak volumes.

How perplexed they must be when the director of NIH -- the gravy train that keeps the vivisectors in cars, boats, and vacation homes -- says that vivisection might not be all that the vivisectors themselves claim it to be.

Director Francis S. Collins understandably dances around the matter; the nation's large universities and the giant suppliers of animals, cages, and tools of torture, are a hornets nest that only the stouthearted would disturb without care. Even the director of the NIH hopes not to lose his job.

Nevertheless, it's hard to look at the gigantic failure of the American biomedical research endeavor and pretend not to notice the key detrimental role that vivisection has played.

Collins: "The average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after adjusting for all of the failures."

Collins: "The upstream component of this developmental pipeline is progressing vigorously, aided by dramatic technological advances and associated basic insights into disease mechanisms ... The downstream end—premarket clinical trials—is traditionally the strong suit of the private sector because of its considerable expertise in assessing promising interventions. However, serious problems exist in the middle zone, in which attrition rates for candidate products are horrendously high. Many of the complex steps in this middle zone have been performed in the same way for a decade or more and have not been subjected to the kind of bold innovation that has characterized other branches of biomedical science."

Collins: "Current trends are indeed disturbing. Over the past 15 years, the annual rate of approval for drugs that address a new target class has not kept pace with the substantially increased investments that have been made in research and development."

Collins: "The use of small and large animals to predict safety in humans is a long-standing but not always reliable practice in translational science. New cell-based approaches have the potential to improve drug safety prediction before use in patients."

Collins: "The use of animal models for therapeutic development and target validation is time consuming, costly, and may not accurately predict efficacy in humans. As a result, many clinical compounds are carried forward only to fail in phase II or III trials; many others are probably abandoned because of the shortcomings of the model. Building on a potentially extensive network of collaborations with academic centers and advocacy groups, NCATS will aim to develop more reliable efficacy models that are based on access to biobanks of human tissues, use of human embryonic stem cell and induced pluripotent stem cell models of disease, and improved validation of assays. With earlier and more rigorous target validation in human tissues, it may be justifiable to skip the animal model assessment of efficacy altogether." Sacrilege!

Collins: "Using as few as one or two human volunteers, phase zero trials allow in vivo testing of very low doses of appropriately labeled novel therapeutics to assess appropriate distribution to the desired target. Through access to academic research centers that received NIH Clinical and Translational Science Awards (CTSAs) and the NIH Clinical Center, NCATS can encourage further development of phase zero technologies such as positron emission tomography–ligand–assisted molecular imaging and metabolomics to provide a more direct pathway toward optimizing formulation, dosing, pharmacokinetics, and pharmacodynamics rather than depending so heavily on animal testing."

The National Institutes of Health (NIH) is informing the research community that it accepts the recommendations of the Institute of Medicine (IOM) in its report Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. As a result, NIH announces that it will not fund any new projects for research involving chimpanzees while the Agency considers and issues policy implementing the IOM’s recommendations.

No local media outlet seems disposed to do much reporting on Kawaoka's apparently successful invention of what may well be a virus even more deadly than the 1918 Spanish flu, the most deadly disease yet encountered by humans, which he helped resurrect from extinction. His newest creation is likely to be even more deadly: a very fast-moving, global, species-eliminating, viral epidemic, should his newest invented virus escape from his lab.

No local media outlet seems disposed to mention his Ebola problems, or UW-Madison's history of biocontainment problems, or researchers' biosafety problems, or the university's misleading public statements about potential risks to the public.

University officials work for an institution which skims literally millions of dollars from Kawaoka's NIH-funded research -- they skimmed over $500,000 in 2011 alone. (Universities negotiate what are called "indirect costs" with the NIH, and then take that amount from NIH grants received by grant recipients. UW-Madison is taking about 40%.) The institution is too financially vested to fairly evaluate the risk to its neighbors -- and every other person on the planet -- and defends Kawaoka's very dangerous work by saying that his lab is absolutely, 100% safe and secure. Pay no attention, they say, to this ticking bomb.

If you think I'm being a little too pessimistic about Kawaoka's lab's or the university's inability (or will) to safeguard public health, you just haven't been keeping up-to-date. Here's a somewhat recent timeline of biosafety related matters involving the university and its staff:

WASHINGTON (AP) — American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.

The Mother of All TargetsNovember 3, 2007H1N1, known colloquially as the 1918 Spanish flu, is the most deadly disease ever encountered.

I am writing with concern regarding the recently completed BSL-3 Agriculture laboratory at the University of Wisconsin, Madison. I understand that the university will be seeking a required CDC inspection of the lab prior to its commission.

As you may know, this lab will be dedicated to research conducted by Dr. Yoshihiro Kawaoka. Recently, it was discovered that Dr. Kawaoka was conducting research with Ebola at the university in a BSL-3 lab and asked for permission from NIH to conduct the research in a BSL-2 lab. NIH responded that the research should be conducted in a BSL-4 lab.

Prior to that, Dr. Kawaoka was apparently conducting research using the 1918 Spanish flu in his Madison lab, and was ordered to stop.

It has come to light that Dr. Kawaoka has continued working with an “altered” Ebola strain in his BSL-2 lab and that neither he nor the University of Wisconsin biosafety committee sought guidance from NIH. (See “UW scientist gains a step on Ebola,” Wisconsin State Journal. 1-22-08. pg 1.)[MSNBC article.]

It seems that there is a general tendency in Dr. Kawaoka’s lab to ease biosafety regulations.

This is worrisome given the deadly nature of the organisms he studies.

I urge the CDC to deny the University of Wisconsin’s request for an inspection of the lab. I urge CDC to find some way to drastically limit the agents that Dr. Kawaoka will be allowed to bring into any lab.

The last thing we need is a 1918 outbreak or the release of a mutated strain of Ebola.

Sincerely,

Rick Bogle

If you are not the appropriate CDC official regarding this matter, please forward this letter to the appropriate officer.

Say what you will, but when others are all coughing up blood, unable to drag the dead from their homes, and are wondering what in the hell happened, I'll be dying too, but at least I'll know more or less what happened and more than a few of those who are to blame.